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Quality and Technical Agreement

Half-day
Life Sciences

This interactive course with workshops is designed to bring you up-to-date with regulatory requirements regarding Quality and Technical Agreements. You get to know a practical approach, applicable for contract givers and acceptors, to establish, implement and update these agreements.

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Audience

Functions involved in the establishment, implementation and updating of Quality and Technical Agreements or auditing of implemented arrangements

Time Schedule
08:30 - 09:00
Registration & coffee
09:00 - 12:00
Course
Price
€ 799

per participant    (excl. VAT)

✓ Exclusive learning approach

✓ Personal course documentation

Lunch, water, coffee & tea

Networking

✓ Course certificate after completion

Location

Quastion Learning Center (Qplus consult BVBA)

Leuvensesteenweg 643 bus 7, 1930 Zaventem, Belgium

Your Trainer

Kristina Bindus

  • Founder & CEO of Qplus consult that focuses on leverage of pharmaceutical expertise across Pharmacovigilance, Medical, Quality, Auditing & Regulatory Affairs.

  • Co-founder of Webcaststudio.be and Belgian internet radio Singjaal.

  • Strategic Advisor & Trainer specialized on interpretation & implementation of EU pharmaceutical law who cares about Quality, Safety and Efficacy of Medicines.

  • Kristina is specialized in online medical communication: webcast, webinar and e-learning.

  • She has developed a universal auditing techniques and coaches auditors to use auditing methodology for an effective assessment result.

  • Kristina has an extensive experience in Quality & Pharmacovigilance.

Program

Roadmap for a practical Approach

  • How to start and what do I need?

  • Who is involved?

  • Which activities require a Quality and Technical Agreement?

GMP and GDP Requirements

  • Duties and responsibilities of contract giver and contract acceptor

  • Outsourced activities

  • Correctly defined, agreed and controller contracted services

  • Suppliers

Structure & Content of Agreements

  • How to create own template

  • Role of QA and Qualified Person/Responsible Person for GDP

  • Basic principles of contractual obligations and responsibilities

  • Content of agreement

  • Definitions

  • Timelines and targets

  • Service/commercial agreements vs Quality and Technical Agreements

Common Pitfalls and how to avoid them

  • Expectations of the Health Authorities

  • The most common pitfalls and tools to avoid them

  • Implementation of the Quality and Technical Agreement arrangements into your own quality system

  • How to evaluate and document your compliance to the agreed arrangements

Duties and Responsibilities of Contract Giver and Contract Acceptor

Contact Quastion for more information about this Quality and Technical Agreement training.
 
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Heading 6

+32 (0) 2 899 05 68

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Leuvensesteenweg 643 bus 7

1930 Zaventem

Belgium

TAV: BE 0822 940 179

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a division of

Qplus consult BV

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